Thailand actively promotes the use of traditional Thai herbs for both health and economic development. To protect consumers, all herbal products manufactured or imported for sale must be properly registered or notified to the Thai Food and Drug Administration (Thai FDA), depending on the product category.
There are three main types of herbal product approval in Thailand
1. Herbal Product Notification (Product Notification or “Jod-Jaeng”)
Herbal products that require notification are divided into two major groups
1.1 Herbal Medicines – Must comply with
– List 1: Traditional Thai Medicine Formulations (131 items)
– List 2: Developed Herbal Medicine Formulations (15 items)
1.2 Health Herbal Products
– List 3: Herbal Health Products (66 items)
Advantages of Notification
– Convenient and fast online submission via the E-licensing system
– Reduces time and cost
– Includes post-marketing surveillance to ensure consumer protection
Examples of products requiring notification
– Herbal body supplements
– General hygiene herbal products such as herbal compresses
2. Herbal Product Detail Modification (Minor Changes Notification)
This applies when minor changes are made to a previously notified product, such as Product name, non-critical ingredients, production method, size, or usage instructions (within permitted limits)
– The claimed benefits must not affect the product category
– Evaluation time is shorter than full registration
3. Traditional Medicine Registration
This is required for herbal products that claim to treat, relieve, prevent, or diagnose diseases.
Registration Requirements
Applicants must prepare documents demonstrating product
3.1 Quality: Raw materials, production process, and product specifications
3.2 Safety (Non-clinical data): Toxicology tests or lab safety assessments
3.3 Efficacy (Clinical data): Research or clinical study results in humans
Examples of products requiring traditional medicine registration
– Herbal pain relievers
– Herbal cough remedies
– Herbal tonics
These products must be manufactured in GMP-certified facilities to ensure their safety and quality.
If entrepreneurs are unsure about the appropriate registration type or the application process, they may consult experts such as Natureprof, which specializes in herbal product law and provides comprehensive FDA registration services.
